Guideline for good clinical practice, version 004

Abstract

Good Clinical Practice is an international ethical and scientific standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. Clinical trials conducted in accordance with this standard will help to assure that the rights, safety and well-being of trial participants are protected and the clinical trial results are reliable. The compliance of all stakeholders to the principles of GCP should be ensured throughout the conduct of the clinical trials.